CIPRAMIL 40MG/ML ORAL DROPS

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
CIPRAMIL® 40MG/ML Oral Drops
(citalopram)
Your medicine is known as the above but will be referred to as Cipramil
throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have further questions, please ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
 If you get any side effects talk to you doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Cipramil is and what it is used for
2. What you need to know before you take Cipramil Drops
3. How to take Cipramil Drops
4. Possible side effects
5. How to store Cipramil Drops
6. Contents of the pack and other information
1.

What Cipramil is and what it is used for

How does Cipramil work?
Cipramil is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a
group of medicines known as antidepressants. These medicines help to correct
certain chemical imbalances in the brain that are causing the symptoms of your
illness.
What is Cipramil used for?
Cipramil contains citalopram and is used for the treatment of depression and,
when you feel better, to help prevent these symptoms recurring. Cipramil is also
used for long-term treatment to prevent the occurrence of new episodes of
depression or if you have recurrent depression. Cipramil is also beneficial in
relieving symptoms if you tend to suffer from panic attacks.
2.

What you need to know before you take Cipramil Drops

Do not take Cipramil Drops
 If you are allergic to citalopram, or any of the other ingredients of this
medicine (listed in section 6). Consult your doctor if you think you might be.
 At the same time as taking medication known as monoamine oxidase
inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid,
isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the
treatment of depression), selegiline (used in the treatment of Parkinson’s
disease) and linezolid (an antibiotic). Even if you have finished taking one of
the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or
tranylcypromine you will need to wait 2 weeks before you start taking
Cipramil. One day must elapse after you have finished taking moclobemide.
After stopping Cipramil you must allow 1 week before taking any MAOI.
 if you are born with or have had an episode of abnormal heart rhythm (seen
at ECG; an examination to evaluate how the heart is functioning).
 if you take medicines for heart rhythm problems or that may affect the heart’s
rhythm (see Other medicines and Cipramil Drops below).
Warnings and Precautions
Please tell your doctor if you have any medical problems, especially if you have:
 Liver disease.
 Kidney disease.
 Diabetes (you may need an adjustment of your antidiabetic therapy).
 Epilepsy or a history of seizures or fits.
 A bleeding disorder or have ever suffered from bleeding in the stomach or
intestine.
 Mania or panic disorder.
 Low blood levels of sodium.
 ECT (electroconvulsive therapy).
 Problems with your eyes, such as certain kinds of glaucoma.
 Suffered or suffer from heart problems or have recently had a heart attack.
 A low resting heart-rate and/or you know that you may have salt depletion as
a result of prolonged severe diarrhoea and vomiting (being sick) or usage of
diuretics (water tablets).
 Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on
standing up which may indicate abnormal functioning of the heart rate.
Please consult your doctor, even if these statements were applicable to you at
any time in the past.
Please note:
Some patients with manic-depressive illness may enter into a manic phase. This
is characterized by unusual and rapidly changing ideas, inappropriate happiness
and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still can also
occur during the first weeks of the treatment. Tell your doctor immediately if you
experience these symptoms.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the
improvement is not achieved immediately. After the start of Cipramil treatment it
may take several weeks before you experience any improvement. In the
beginning of the treatment certain patients may experience increased anxiety,
which will disappear during continued treatment. Therefore, it is very important
that you follow exactly your doctor’s orders and do not stop the treatment or
change the dose without consulting your doctor.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have
thoughts of harming or killing yourself. These may be increased when first starting
antidepressants, since these medicines all take time to work, usually about two
weeks but sometimes longer.
You may be more likely to think like this:
 If you have previously had thoughts about killing or harming yourself.
 If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your
doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed
or have an anxiety disorder, and ask them to read this leaflet. You might ask them
to tell you if they think your depression or anxiety is getting worse, or if they are
worried about changes in your behaviour.
Use in children and adolescents under 18 years of age
Cipramil should normally not be used for children and adolescents under 18
years. Also, you should know that patients under 18 have an increased risk of
side-effects such as suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and anger) when they take
this class of medicines. Despite this, your doctor may prescribe citalopram for
patients under 18 because he/she decides that this is in their best interests. If
your doctor has prescribed Cipramil for a patient under 18 and you want to
discuss this, please go back to your doctor. You should inform your doctor if any
of the symptoms listed above develop or worsen when patients under 18 are
taking Cipramil.

Also, the long-term safety effects concerning growth, maturation and cognitive
and behavioural development of Cipramil in this age group have not yet been
demonstrated.
Other medicines and Cipramil Drops
Medicines may affect the action of other medicines and this can sometimes cause
serious adverse reactions.
Please tell your doctor or pharmacist if you are taking, have taken or might take
any other medicines This includes other medicines for depression (see Do not
take Cipramil Drops above).
 The herbal remedy St John's wort (Hypericum perforatum). This should not be
taken at the same time as Cipramil.
 Monoamine oxidase inhibitors (MAOIs). These should not be taken at the
same time as Cipramil (see Do not take Cipramil Drops above).
Tell your doctor if you are taking any of the following medicines:
 Linezolid (an antibiotic).
 Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel
unwell when using these medicines with Cipramil you should see your doctor.
 Lithium (used to prevent and treat mania) and tryptophan (an antidepressant).
Pimozide (a neuroleptic). This should not be taken at the same time as Cipramil.
 Imipramine and desipramine (used to treat depression).
 Medicines containing selegiline (used to treat Parkinson’s disease)
 Cimetidine (used to treat stomach ulcers).
 Mefloquine (used to treat malaria).
 Bupropion (used to treat depression).
 Medicines known to affect the blood platelets (e.g. anticoagulant drugs used
to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory
drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers; and
some antipsychotic drugs and tricyclic antidepressants).
 Metoprolol, a beta blocker used to treat migraine, some heart conditions and
high blood pressure. The effects of either drug could be increased, decreased
or altered.
 Neuroleptics (used in the treatment of schizophrenia).
Do not take Cipramil if you take medicines for heart rhythm problems or
medicines that may affect the heart’s rhythm, e.g. such as Class IA and III
antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide,
haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g.
sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment
particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you
have any further questions about this you should speak to your doctor.
Taking Cipramil with food, drink and alcohol
Cipramil can be taken with or without food (see section 3 “How to take Cipramil
Drops”).
As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving
treatment although Cipramil has not been shown to increase the effects of
alcohol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. If you are
pregnant, think you might be pregnant, or are trying to become pregnant, tell your
doctor. Do not take Cipramil if you are pregnant unless you and your doctor have
discussed the risks and benefits involved.
Make sure your midwife and/or doctor know you are on Cipramil. When taken
during pregnancy, particularly in the last 3 months of pregnancy, medicines like
Cipramil may increase the risk of a serious condition in babies, called persistent
pulmonary hypertension of the newborn (PPHN), making the baby breathe faster
and appear bluish. These symptoms usually begin during the first 24 hours after
the baby is born. If this happens to your baby you should contact your midwife
and/or doctor immediately. Also, if you take Cipramil during the last 3 months of
your pregnancy and until the date of birth you should be aware that the following
effects may be seen in your newborn: fits, being too hot or cold, feeding
difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes,
tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping
difficulties. If your newborn baby gets any of these symptoms please contact your
midwife and/or doctor immediately.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breast-feeding, ask your doctor for advice. You should not breast-feed
your baby when taking Cipramil because small amounts of the medicine can pass
into the breast milk.
Fertility
Citalopram has been shown to reduce the quality of sperm in animal studies.
Theoretically, this could affect fertility, but impact on human fertility has not been
observed as yet.
Driving and using machines
Cipramil does not usually affect the ability to carry out normal daily activities.
However, if you feel dizzy or sleepy when you start to take this medicine, you
should be careful when driving, operating machinery or performing jobs that need
you to be alert until these effects wear off.
Important information about some of the ingredients of Cipramil Drops
This medicinal product contains small amounts of ethanol (alcohol), less than 100
mg in all doses. These drops also contain the preservatives E216 and E218,
which may cause allergic reactions (possibly delayed).
3.

How to take Cipramil Drops

How much to take
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Adults
Depression
The usual dose is 16 mg (8 drops) per day. This may be increased by your doctor
to a maximum of 32 mg (16 drops) per day.
Panic disorder
The starting dose is 8 mg (4 drops) per day for the first week before increasing
the dose to between 16 –24 mg (8 to 12 drops) per day. The dose may be
increased by your doctor to a maximum of 32 mg (16 drops) per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g.
8-16 mg per day. Elderly patients should not usually receive more than 16 mg (8
drops) per day.
Children and adolescents (less than 18 years of age)
Cipramil should not be given to children or adolescents under 18 years of age.
For further information, please see section 2, What you need to know before
you take Cipramil Drops.
Patients with special risks
Patients with liver complaints should not receive more than 16 mg (8 drops) per
day.
If you have previously taken Cipramil tablets, you will find that the dose of your
medicine in mg given as drops is a bit lower than that of tablets. This is because
your body more easily absorbs the drops than the tablets, so you do not need as
many mg to have the same effect.

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